Kornimate/medical-research-clean huggingface dataset:
significance of routine hysteroscopy prior to a first 'in vitro fertilization'(ivf) treatment cycle

Conditions: Intrauterine Abnormalities in Infertility

Summary: background: despite the numerous advances in the field of in vitro fertilisation/intracytoplasmic sperm injection (ivf/icsi), there still exists a maximum implantation rate per embryo transferred of about 30%. next to the physiological and physic burden that comes with every ivf treatment cycle, implantation failure also adds up to the considerable costs associated with art. studies have shown, that minor intrauterine abnormalities can be found in 11-40% of the infertile women with a normal transvaginal sonography. detection and treatment of these abnormalities by office hysteroscopy have led to a 9-13% increase in pregnancy rate. therefore, it is increasingly advocated to screen all infertile women on intracavitary pathology prior to the start of ivf/icsi. objective: the aim of the proposed study is to assess whether diagnosing and treating unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office hysteroscopy prior to a first ivf/icsi treatment cycle improves the cost-effectiveness of the fertility treatment. study design: multicenter randomized intervention study. population: asymptomatic women, indicated for a first ivf/icsi treatment cycle and a normal transvaginal ultrasonography. intervention: participants will be randomized for a (sis and) hysteroscopy with treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up. in both groups standard ivf/icsi treatment will be initiated. primary outcome measure: cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of ivf/icsi treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles) secondary outcome measure: * cumulative implantation rate achieved within 18 months of ivf/icsi treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles) * cumulative miscarry rate within 18 months of ivf/icsi treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles) * cost calculations of, sis, hysteroscopy procedures and the ivf treatment * patient preference and tolerance of a sis and diagnostic/therapeutic hysteroscopy procedure * prevalence of unexpected intrauterine abnormalities * diagnostic accuracy of sis in diagnosing intrauterine abnormalities


Eligibility criteria:
inclusion criteria: * women indicated for a first ivf/icsi treatment * primary or secondary infertility * normal transvaginal ultrasound, performed in the follicular phase of the menstrual cycle exclusion criteria: * recurrent miscarriage * prior hysteroscopy treatments * meno-metrorrhagia (defined as any intermenstrual loss of blood)

Keywords: hysteroscopy infertility subfertility intrauterine abnormalities intracavitary pathology ivf icsi in vitro fertilization intracytoplasmic sperm injection
investigating nutrition and functional outcome in critically ill patients

Conditions: Neurosurgical Patients; Elderly Patients; Obese Patients; Cardiac Surgery Patients; Abdominal Surgery Patients

Summary: this is a single-center, multi-icu prospective observational trial evaluating current nutritional practice and its influence of the physical function of critically ill patients.

the investigators propose a prospective observational, single-center, multi-intensive care unit trial to evaluate the influence of current nutritional practice on the physical outcome in critically ill patients. at least 100 consecutive patients requiring surgery, who are admitted to any surgical icu at the university hospital rwth aachen will be recruited. nutritional practices, such as dosage, timing and route of administration of the nutrition, as well as complications regarding the nutrition will be recorded and analyzed longitudinally from icu-admission until hospital discharge. patient outcomes, such as icu- and hospital length of stay, duration of mechanical ventilation, organ dysfunction, complications and infections will be evaluated. to assess physical function of the patient, muscle mass, muscle strength, the ability of the patient to self-mobilize and perform every day activities will be measured. this observational trial aims to assess the current standard of nutritional practice in the icu, to detect problems and complications and to gather first evidences about the influence of nutrition on the physical function of the patient. this study also aims to compare the outcome of the predefined subgroups of critically ill patients.

Eligibility criteria:
inclusion criteria: * informed consent * adult patients (≥ 18 years) * patients admitted to a surgical icu requiring surgical intervention * patients requiring sedation and invasive ventilation for ≥ 48 hours * patients with an expected icu-length of stay ≥ 72 hours exclusion criteria: * pregnant or lactating patients * patients already receiving an intense nutrition support (home parenteral or enteral nutrition) in addition to normal nutrition on hospital admission * patients with disabling disease (neurological or physical) that prevents them from walking, sitting or standing before icu admission * patients unable to follow orders from the study personnel (language barriers, neurological, psychiatric disorders) * death expected within 96 hours after admission due to severity of disease * enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case by case basis)
malnutrition assessment tools in surgery

Conditions: Malnutrition; Surgery--Complications

Summary: the purpose of this study is to evaluate the main malnutrition risk assessment tools in patients undergoing operations of general surgery.

this is a multi centre prospective observational study including patients undergoing major/major+ operation of general surgery. patients will be interviewed by surgical trainees and their malnutrition risk will be assessed with the use of sga, must, nrs, mna-sf etc. clinical variables and demographics will also be recorded in order to enable meaningful comparisons of malnutrition risk assessment tools in terms of serious postoperative complications.

Eligibility criteria:
inclusion criteria: * age \>18 years * patients undergoing elective or emergency surgery. urgency of emergent operations is classified as follows, according to the clinical judgment of the surgeon, regarding the maximum time a patient could wait for surgery: * 3.expedited (\>18 hours) * 2b. urgent (6-18 hours) * 2a. urgent (2-6 hours) * 1. immediate (\<2 hours) * operations involving the gastrointestinal tract * magnitude of operation graded by possum \[17,18\]: * major+ (examples include colonic resection abdominoperineal resection of the rectum, radical total gastrectomy, intestinal bypass, whipple resection) * major (examples include adhesiolysis, stoma formation, small bowel resection, anterior resection, cholecystectomy and exploration of the bile duct) exclusion criteria: * age \<18 years * magnitude of operation graded by possum: * minor * intermediate * inability to perform nutritional assessment * inability to provide informed consent

Keywords: nutrition malnutrition malnutrition risk tools nutritional assessment surgery
pgl5001 proof of concept study in inflammatory endometriosis

Conditions: Endometriosis

Summary: this is a prospective, three-part (part a1, part a2 and part b),phase ii study investigating the efficacy, safety, pharmacokinetics and pharmacodynamics of the jnk inhibitor pgl5001 orally administered for up to 5 months with concomitant dmpa administration for the treatment of laparoscopically diagnosed inflammatory endometriosis. the part a1 is open-label, the parts a2 and b are double-blind. the target population will be women of reproductive age and suffering from newly diagnosed peritoneal and/or ovarian endometriosis.


Eligibility criteria:
inclusion criteria: * the subject must provide written informed consent prior to initiation of any study related procedures. * the subject must be an adult woman of reproductive age, aged from 18 and above. * the subject must be a newly diagnosed patient suffering from peritoneal and/or ovarian endometriosis with at least 15% of the endometriotic lesions observed at the study diagnostic laparoscopy being red inflammatory lesions and with a proven histological diagnosis. * the subject must consent to the scheduling of a second laparoscopy for surgical treatment at the study end. * the subject must have a history of pelvic pain for at least 3 months prior to the screening visit. exclusion criteria: * the subject is over 40 years old and has a fsh serum level during day 2-4 of her cycle ≥ 21.5 miu/ml. * the subject has a positive pregnancy test at baseline or is breast-feeding or planning a pregnancy during the course of the study. * the subject is known for having a cause of chronic abdominal/pelvic pain other than endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis). * the subject has a history of surgical treatment for endometriosis prior to the study diagnostic laparoscopy. * the subject is requiring urgent surgical excision of endometriotic lesions at the time of first diagnostic laparoscopy. * the subject has a history (in the past 12 months) of or a current medical treatment for endometriosis other than nsaid (e.g. gnrh agonist or antagonist, danazol, continuous oral combined oestroprogestogens).
study to assess the efficacy and safety of three doses of pt001 in japanese subjects with moderate to severe copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the overall objective of this study was to assess the efficacy and safety of gp mdi relative to placebo in japanese subjects with moderate to severe copd. each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.

this was a randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center study to assess the efficacy and safety of 3 doses of gp mdi (28.8, 14.4, and 7.2 μg ex-actuator, bid) in japanese subjects with moderate to severe copd. subjects who met the entry criteria had their maintenance therapy for copd adjusted, as specified in the protocol. to allow for an adequate washout of previous maintenance medications, subjects underwent a washout period of at least 7 days, but not greater than 28 days duration prior to returning to the clinic for visit 2 (randomization visit; day 1 of treatment period 1). the 4 study treatments were gp mdi 28.8, 14.4, and 7.2 μg ex-actuator, and placebo mdi bid. subjects were randomly assigned to 1 of the following 4 treatment sequences (abcd, bdac, cadb, dcba) in a 1:1:1:1 ratio using an interactive web response system where each letter represented 1 of the 4 treatments included in the study by random assignment. subjects were to complete 7 days of dosing in each of the 4 treatment periods, with each treatment period separated by a washout period of 5 to 21 days.

Eligibility criteria:
inclusion criteria: * clinical history of copd with a moderate to severe classification * current and former smokers with a history of at least 10 pack-years of cigarette smoking. -post-bronchodilator fev1 must be ≥30% and \<80% predicted normal value- exclusion criteria: * pregnancy * primary asthma diagnosis; poorly controlled copd defined as acute worsening of copd that required treatment with corticosteroids or antibiotics in the 6-week interval prior to screening or between screening and visit 2; * clinically significant abnormal ecg * other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea; cancer that was not in complete remission for at least 5 years; * diagnosis of angle closure glaucoma * a documented myocardial infarction within 1 year of screening.
high-fermented food intervention among locally advanced rectal cancer patients (the feed trial)

Conditions: Rectal Cancer; Non-Small Cell Lung Cancer

Summary: the purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (feed-ff) that includes fermented foods (ff), among locally advanced rectal cancer patients and non-small cell lung cancer (nsclc) patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiation and nsclc patients receiving immunotherapy.


Eligibility criteria:
inclusion criteria for gi patients: * 18 years of age or older * diagnosed with locally advanced rectal cancer (stage ii-iii) * will undergo neoadjuvant chemoradiation at moffitt cancer center * able to pick up ffs once/weekly at moffitt * able to speak and read english * able to consume foods orally * able to provide informed consent inclusion criteria for thoracic patients: * 18 years of age or older * diagnosed with stage ii-iv non-small cell lung cancer (nsclc) * will undergo immunotherapy with immune checkpoint inhibitors (+/- chemotherapy or other treatment) at moffitt cancer center * able to pick up ffs once/weekly at moffitt * able to speak and read english * able to consume foods orally * able to provide informed consent exclusion criteria: * antibiotic use within 1 month prior to baseline * if currently using probiotics, unwillingness to cease probiotic use * previous receipt of surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor * per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, crohn's disease) * infectious disease diagnosed \<1 month prior to baseline * already consuming ≥2 servings of fermented foods/day * previously diagnosed with a mast cell disorder or histamine allergy

Keywords: locally advanced rectal cancer non-small cell lung cancer
donafenib plus sintilimab for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: this study will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (hcc).

this is a phase ii study to evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hcc. 30 subjects with advanced hcc (barcelona-clinic- liver-cancer \[bclc\] stage c, or china liver cancer staging \[cnlc\] iiia/iiib) will be enrolled in the study. part 1 (safety run-in): 6 patients will receive donafenib 200mg p.o. bid and sintilimab 200mg i.v. for a 21-day cycle. part 2: patients will receive donafenib at the recommended phase 2 dose determined from part 1 and sintilimab 200mg i.v. q3w. donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Eligibility criteria:
inclusion criteria: * advanced hcc (bclc stage c or cnlc iiia/iiib ) with diagnosis confirmed by histology/cytology or clinically * patients who have tumor recurrence after surgical resection or ablation are allowed to be included * patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included * at least one measurable lesion * child-pugh score ≤7 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ and hematologic function * life expectancy of at least 3 months exclusion criteria: * diffuse hcc * macrovascular invasion involving the main trunk or inferior vena cava * central nervous system metastasis * history of malignancy other than hcc * esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment * uncontrolled ascites * history of hepatic encephalopathy * patients who received prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or hepatic arterial infusion chemotherapy (haic) for hcc * history of organ and cell transplantation * active severe infection; use of antibiotics within 2 weeks prior to injection of sintilimab * autoimmune disease or immune deficiency * severe organ (heart, kidney) dysfunction

Keywords: hepatocellular carcinoma donafenib sintilimab tki pd-1 inhibitor
gestational diabetes mellitus and neurodevelopment in newborns

Conditions: Diabetes, Gestational; Glucose Metabolism Disorders

Summary: the purpose of this study is to evaluate the feasibility of using a quantitative eeg method to evaluate neurodevelopment in newborns and to evaluate whether subtle neurodevelopmental deficits can be detected in newborns from mothers with gestational diabetes mellitus (gdm) compared to control newborns. the second purpose of this study is to determine whether cord blood concentration in docosahexaenoic acid (dha), an omega-3 fatty acid, is similar in neonates of well-controlled mothers with gestational diabetes mellitus (gdm) compared to control mothers, and to evaluate whether this contributes to neonates neurodevelopment status.

maternal weight is measured close to delivery and bmi is calculated. birth weight, length, head circumference, apgar score and glycaemia are recorded at birth. an eeg are performed on the newborn within 48 hrs after birth.a maternal blood sample is collected at admission to measure maternal glycated hemoglobin (a1c). cord blood samples are collected in the umbilical vein after delivery.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * aged between 18 and 40 years exclusion criteria: * smoking, * illicit drug consumption, * omega-3/6 consumption, * liver or renal disease, * cancer * any medical conditions affecting glucose/lipid metabolism.

Keywords: neurodevelopment electroencephalography gestational diabetes mellitus omega 3 polyunsaturated fatty acids
clinical study of ard103 car-t therapy for patients with r/r aml or mds

Conditions: Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia Refractory; MDS (Myelodysplastic Syndrome)

Summary: this is a phase i/2, interventional, open-label, multicenter study to assess the safety and efficacy of ard103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

the investigational product (ip) for this study is ard103, a c-type lectin-like molecule-1 (cll-1) autologous chimeric antigen receptor t-cells (car-t). cll-1 is highly expressed on both myeloid blasts and leukemia stem cells (lscs) but is absent on normal hematopoietic stem cells (hscs), suggesting cll-1 as an excellent therapeutic target for aml and hence other potential myeloid malignancies.

Eligibility criteria:
inclusion criteria: * documented diagnosis of aml with either refractory or relapsed disease or diagnosis of mds and ≥ 5% bm blasts * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic status: * absolute lymphocyte count (alc) \> 100/mm3 * adequate renal, hepatic, cardiac and pulmonary function: * alt and ast \< 3.0 × the uln * creatinine clearance ≥ 45.0 ml/min as estimated by cockcroft-gault and independent dialysis * total bilirubin ≤ 2.0 mg/dl * pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test * contraception: males and females of childbearing potential must agree to use an effective method of contraception * participant is capable of giving signed informed consent exclusion criteria: * participants with acute promyelocytic leukemia * presence of active and clinically relevant central nervous system (cns) disorder * autoimmune disease requiring immunosuppressive treatment * participants with known hepatic bridging cirrhosis * currently active infection with hepatitis b or c * previous treatment with investigational gene or cell therapy (including car therapy) * any active acute gvhd or systemic treatment of more than 10 mg prednisone daily (or equivalent) * previous chemotherapy including biologic/targeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration
feasibility and efficacy of brief behavior change counseling on lifestyle in hypertensive and diabetics participants

Conditions: Hypertension; Diabetes; Life Style

Summary: the purpose of this study will be to assess the feasibility and the preliminary efficacy of brief behavior change counseling on lifestyle among diabetic and hypertensive patients

1. background noncommunicables diseases (ncds) are on the rise globally as well as in malawi, alongside their behavioral modifiable risk factors. behavioral intervention such as brief behavior change counseling using 5a's and a guiding style (bbcc + 5as +gs) has shown an effect on reducing these lifestyles risk factors. their effectiveness varies between the behavioral technique used. but so far, available evidences of this effect are from western countries. even implementation of these techniques has been done in some countries, but so far there is no information about their implementation in noncommunicable diseases field in mangochi, even malawi. therefore, a really need to conduct this study in mangochi, southern malawi. 2. objectives 1. overall objective: the primary objective of the study is to test the feasibility of the brief behavior change counseling using 5 a's and a guiding style from motivational interviewing which will be used for ncds 'patients and assess its efficacy in improving lifestyle risk factors in ncds' patients. 2. specific objectives for this study are 1. to evaluate the feasibility of participating in a future quasi-experimental study of bbcc + 5a's + gs ; 2. to estimate the efficacy of bbcc + 5a's + gs from mi on lifestyle risk factors, theory constructs, quality of life domains; 3. to provide data on which to estimate the sample size required to detect a statistically significant difference between experimental and control groups; 4. and to explore experience of participants and care providers during the brief behaviour change counseling sessions to ncds' patients in mangochi 4. methodology: 1. design: mixed methods (pilot quasi-experimental and qualitative study) 2. settings: the study will take place at two sites: mangochi district hospital and monkey bay community hospital; malawi. 3. sample size: purposeful sampling and successive eligible patients. sample size: efficacy study will be conducted on 50 patients. 4. intervention: brief behaviour change using 5a's and a guiding style from motivational interviewing will be administered to participants in the intervention group by trained counsellors (nurses).

Eligibility criteria:
inclusion criteria: * aged between 18-65 years old, * registered in the clinic at least for 6 months, * been screened for at least 1 lifestyle risk factor, * express willingness to participate in the study, * being permanent resident in mangochi district for at least 12 months from recruitment, and * fluent in chichewa and/or yao exclusion criteria: * - present with any concomitant severe disease, * being pregnant * patient with an active psychiatrics' comorbidity

Keywords: lifestyle diabetics hypertensives brief behavior change counseling motivational interviewing 5 a's